Cleared Traditional

K904177 - GALIX MA-6C HOLTER CASSETTE RECORDER

K904177 is an FDA 510(k) clearance for GALIX MA-6C HOLTER CASSETTE RECORDER, manufactured by Galix Instrumentacion Biomedica. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K904177 · Galix Instrumentacion Biomedica · Cardiovascular device
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Sep 1991
Decision
374d
Days
Class 2
Risk

K904177 is an FDA 510(k) clearance for the GALIX MA-6C HOLTER CASSETTE RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Galix Instrumentacion Biomedica (Buenos Aires, AR). The FDA issued a Cleared decision on September 20, 1991 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Galix Instrumentacion Biomedica devices

FDA 510(k) Submission Details - K904177

510(k) Number K904177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1990
Decision Date September 20, 1991
Days to Decision 374 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 125d · This submission: 374d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 121
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K904177.
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SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION
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MR-5200 FULL DISCLOSURE SYSTEM
K911257 · Mennen Medical, Inc. · Aug 1991
PR4
K911097 · Mortara Instrument, Inc. · Aug 1991
MODEL 9101 RECORDER/ANALYZER SYSTEM
K901251 · Aequitron Medical, Inc. · May 1990